Non-invasive Phrenic Nerve Stimulation in ARDS Patients - a Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ARDS, Human
- Sponsor
- Southeast University, China
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- The speed of successful non-invasive electrical stimulation deployment
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality. Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury and ventilator-induced diaphragm dysfunction, thereby improving patient outcomes. Surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with ARDS undergoing mechanical ventilation remain unclear and require further investigation.
Detailed Description
Mechanical ventilation is an important treatment for patients with acute hypoxemic respiratory failure (AHRF). However, reduced diaphragmatic activity during mechanical ventilation can lead to diaphragmatic disuse atrophy, atelectasis, increased lung stress and strain, and hemodynamic impairment. This, in turn, may prolong the duration of mechanical ventilation, make weaning more difficult, and even increase mortality in these patients. In patients with AHRF undergoing mechanical ventilation, maintaining moderate spontaneous breathing under lung and diaphragm protective ventilation remains challenging. Synchronizing phrenic nerve stimulation to promote diaphragmatic activity may prevent ventilator-induced lung injury (VILI) and ventilator-induced diaphragm dysfunction (VIDD), thereby improving patient outcomes. Surgically implanted phrenic nerve stimulation has been used in certain neurological disorders, but the effects of percutaneous non-invasive synchronized phrenic nerve stimulation in patients with acute respiratory distress syndrome (ARDS) undergoing mechanical ventilation remain unclear and require further investigation.
Investigators
Ling Liu
Director of Intensive Care Unit, Principal Investigator, Clinical Professor
Southeast University, China
Eligibility Criteria
Inclusion Criteria
- •Adult ARDS patients undergoing controlled mechanical ventilation
- •The duration of endotracheal intubation \< 48 hrs
Exclusion Criteria
- •Neurological condition affecting motor neuron or muscle (e.g. ALS)
- •Paralysis of the phrenic nerve
- •Proven or suspected spinal cord injury
- •Conditions that limit diaphragm movement
- •Patients with Implanted cardiac support systems (pacemaker, implanted defibrillator)
- •Patients with implanted medical pumps
- •Patients with skin lesions, infections or strictures in throat/neck area
- •Patients with metallic implants
- •Refusal to sign informed consent
Outcomes
Primary Outcomes
The speed of successful non-invasive electrical stimulation deployment
Time Frame: Procedure (from enrollment to extubation)
Time between first successful electrical phrenic stimulation and identification of the optimal stimulation locus in seconds
Frequency of enough Tidal volume
Time Frame: Procedure (from enrollment to extubation)
Percentage of stimulated breaths above the cut-off target tidal volume (3-6 ml/kg ideal body weigh) out of the total number of stimulated breaths
Secondary Outcomes
- Driving pressure(Procedure (from enrollment to extubation))
- Diaphragm excursion(up to 28 days)
- Respiratory system compliance(Procedure (from enrollment to extubation))
- Diaphragm thickening fraction(up to 28 days)
- ventilation distribution(Procedure (from enrollment to extubation))
- Maximal inspiratory pressure (MIP)(Procedure (from enrollment to extubation))